CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy

Completed · Not applicable

Conditions studied: Neonatal Hypoxic-Ischemic Encephalopathy (HIE)

In brief

This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain. In this study, half of the babies (selected at random) will have a special cooling cap with circulating water placed on their head for 72 hours to lower the temperature of their brain. The rest of the baby's body will be maintained at a defined temperature by a standard overhead radiant heater. The study protocol includes the taking and analysis of blood samples, performance of brain wave tests, imaging of the brain by ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be assessed at 18 months of age.

Key facts

Study ID

NCT00383305

Run by

Olympic Medical

People needed

235

Starts

1999-07-01

Expected to finish

2003-09-01

Last updated by the study team

2006-10-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants are assessed sequentially by criteria A, B and C listed below. Infant must meet all three criteria to be eligible for trial enrollment.
• Criteria A: Infants >= 36 weeks gestation admitted to the NICU with ONE of the following:
• Apgar score of <= 5 at 10 minutes after birth;
• Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth;
• Acidosis defined as either umbilical cord pH or any arterial pH within 60 minutes of birth < 7.00; or
• Base Deficit <= -16 mmol/L in umbilical cord blood sample OR any blood sample within 60 minutes of birth (arterial or venous blood).
• Criteria B: Moderate to severe encephalopathy consisting of altered state of consciousness (as shown by lethargy, stupor, or coma) AND at least one or more of the following:
• Hypotonia;
• Abnormal reflexes, including oculomotor or pupillary abnormalities;
• An absent or weak suck;
• Clinical seizures
• Criteria C: At least 20 minutes duration of amplitude integrated EEG (aEEG/CFM) recording that shows abnormal background aEEG/CFM activity or seizures. The aEEG/CFM is to be performed from one hour of age. If subsequently an abnormal aEEG/CFM is recorded before 5.5 hours of age, the infant is then eligible for enrollment. The aEEG is not to be performed within 30 minutes of IV anticonvulsant therapy as this may cause suppression of EEG activity. In particular, high dose prophylactic anticonvulsant therapy (e.g., >20 mg/kg phenobarbitone) is not to be given prior to performing the aEEG/CFM.

You may not qualify if…

• Infant expected to be > 5.5 hours of age at the time of randomization
• Prophylactic administration of high dose anticonvulsants (e.g., >20 mg/kg phenobarbitone). After trial entry phenobarbitone or other anticonvulsant therapy is allowed to be given as clinically indicated to treat seizures.
• Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis
• Imperforate anus
• Evidence of head trauma or skull fracture causing major intracranial hemorrhage
• Infant < 1,800 g birth weight
• Head circumference < (mean - 2SD) for gestation if birth weight and length are > (mean - 2SD)
• Infant "in extremis" (i.e. an infant for whom no other additional intensive management would be offered in the judgment of the attending neonatologist)
• Unavailability of essential equipment (e.g., Cool-Cap, aEEG/CFM)
• Planned concurrent participation in other experimental treatments

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• University of California San Diego Medical Center (Hillcrest) — San Diego, California, United States
• University of California San Francisco Children's Hospital — San Francisco, California, United States
• Children's Hospital of Denver — Denver, Colorado, United States
• Children's Memorial Hospital / Prentice Women's Hospital — Chicago, Illinois, United States
• University of Illinois at Chicago Medical Center — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan Medical Center - Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospital and Clinics of Minneapolis — Minneapolis, Minnesota, United States
• Schneider Children's Hospital — New Hyde Park, New York, United States
• Children's Hospital of new York - Presbyterian (Columbia University) — New York, New York, United States
• Golisano Children's Hospital at Strong — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Children's Hospital of Oklahoma — Oklahoma City, Oklahoma, United States
• AI Dupont Children's Hospital at Thomas Jefferson University Medical Center — Philadelphia, Pennsylvania, United States
• Magee Women's Hospital / Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Royal Alexandra Hospital — Edmonton, Alberta, Canada
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Children's Hospital of Eastern Ontario / The Ottawa Hospital — Ottawa, Ontario, Canada
• University of Auckland - National Women's Hospital — Auckland, New Zealand
• Southmead Hospital — Bristol, England, United Kingdom
• St. Michael's Hospital — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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